Vacuum treatment array and film for producing a vacuum treatment array

ABSTRACT

The invention relates to a vacuum treatment array having at least one open-pored contact element, by way of which a negative pressure and/or suction can be generated in a body cavity, wherein the open-pored contact element is configured, at least in sections, in the manner of a tube, having an outer and/or inner boundary surface rotating around a tube axis, at least in part.

The invention relates to a negative pressure treatment arrangementhaving at least one open-cell contact element, by way of which negativepressure and/or suction can be generated in a body cavity.

Conventional negative pressure treatment or vacuum therapy (low pressurewound therapy) is used for the treatment of external wounds. Anopen-cell polyurethane sponge or an open-cell fluid-collecting means isplaced into the wound, sealed using a film, and then subjected tonegative pressure. Under the film, assisted by the negative pressure,wound cleansing and wound healing can take place.

Endoscopic vacuum therapy or negative pressure treatment is used for thetreatment of internal wounds. Its effectiveness was initiallydemonstrated in suture leaks at the rectum, and then also in intestinalleaks at other locations as well as in the area of the esophagus, thestomach, the small and large intestines. In the case of internal wounds,cavities, abscesses, empyema, fistulae or similar situated under theskin surface, which are or are made endoscopically accessible by way ofan port outwards, endoscopic vacuum therapy can be used for woundtreatment. In endoscopic vacuum therapy, the natural or artificialaccess routes to hollow organs, gastrointestinal tract and body cavitiesare endoscopically used.

Open-cell polyurethane foam drains are introduced using endoscopesinternally, intracorporally, intraluminally and intracavitarily. In theintraluminal therapy variant, the sponge element is placed in anintestinal lumen at the level of the defect. In the intracavitaryvariant, the sponge element is introduced through the defect into anextraluminal wound cavity.

Within the scope of the specification of the invention herein,intraluminal regions as well as extraluminal regions are called bodycavities.

The two above-mentioned therapies can also be combined. Afterpositioning the sponge element, via the outward-conducted drainage tube,negative pressure or suction is applied. The body cavity (wound cavityor intestinal lumen) collapses subject to the suction, together with theelastic sponge element. The sponge surface adheres to the wound surfaceby suction, suction cup-like. As a result of the suction, at the sametime, the sponge thus attaches itself also to the placement location.Effective wound drainage takes place. At the same time, the wound defectis closed. Subject to the lasting drainage effect and vacuum applicationto the wound surface, the wound is cleaned, granulation tissue forms,and secondary wound healing takes place. At intervals of several days,an endoscopic change of the drainage sponge is made.

Within the scope of the invention, a corresponding sponge drain is alsoreferred to as contact element.

For placement of a sponge drain or a contact element in the rectum forthe treatment of postoperative anastomotic failures, an approvedplacement system exists.

For placement of the contact elements or sponge drains in lower-lyingregions of the body, such as the large intestine, the esophagus or theduodenum, having partially winding access paths, sponge drains are used,which comprise a drainage tube, to the end of which the contact elementis sewn. The appropriate sponge element is grasped using grippingpliers, polyp grippers or slings and inserted subject to endoscopicdirection.

For draining wound secretions, body fluids, suppuration andpost-surgery, drainage tubes are inserted. They are tubes, into theinner lumen of which, through lateral perforations, secretions or gasescan be drained. The drainage may take place as gravity drainage,overflow drainage, capillary drainage or subject to suction. Drains mayalso be designed as tubular drains or else as planar drains. Specialdrains, e.g. for bile congestion drainage, are also inserted surgicallyor endoscopically. Via drains, flushing can also take place. Drains canbe subjected to negative pressure.

Wound drains usually develop their effect only immediately after anoperation because fibrin precipitation, blood coagulation and tissuecontact, inter alia, result in rapid clogging of the drainage ports.Whether drainage is possible also depends on the nature of the materialto be drained. Feces, saliva or pus are viscous and require relativelylarge-lumen perforations, while urine, ascites, bile and the like arevery flowable and can be drained by way of small-lumen ports, too.

Conventional drains consist of a tube, on which one or a plurality oflateral perforations are located. The ports communicatefluid-conductively directly with the inner lumen of the drain.

For an open-cell sponge drain or an open-cell contact element, adrainage tube equipped with perforations is introduced into an open-cellsponge. The drainage tube is fluid-conductively connected, via theperforations, to the open-cell fluid-collecting element. The sponge actslike a filter. As a result of the open-cell sponge structure, when anegative pressure is applied, the sponge surface can adhere to a woundor the wound margins by suction over a large area. The cell ports of thesponge act like little suction cups. As a result of the open-cellstructure of the fluid-collecting means or the contact element, thenumerous perforations communicate with each other fluid-conductively.This assures the maintenance of an applied negative pressure to theadjacent wound surface, even when individual cells are clogged. Eventhough a secretion can only be suctioned off by way of a small surface,this drainage is also assured by the open-cell communication of thenumerous cells with each other. This is a substantial difference fromthe conventional drainage tubes, where a tube has individualperforations. Once these ports are clogged, because of the missingconnection between the individual perforations (except by way of theinner lumen of the tube) any suction and drainage effect is interrupted.

EP-A-12001013.7 describes a negative pressure treatment arrangement, inwhich the contact elements are formed by two open-cell drainage layers.The cells of the open-cell drainage layers communicate with each otherby way of the drainage space situated in between. Between the twodrainage layers, a suction arrangement, connectable to a suction device,for suctioning off any exudate that gets between the drainage layers isarranged. To promote wound healing, the suction arrangement of thisprior art negative pressure treatment arrangement has a flushingarrangement for supplying a fluid between the drainage layers allocatedto it. Through the flushing arrangement, a fluid flows into the bodycavity. As a result, the flow in the suction arrangement is continuouslymaintained. Coagulations are avoided because bottom exudate iscontinuously suctioned off by the suction arrangement toward the suctiondevice.

By reference thereto, the disclosure content of the document herein isexpressly incorporated into specification herein with respect to theembodiment of the drainage layers and the suction device or flushingarrangement arranged between the drainage layers.

When using conventional negative pressure treatment arrangements of thetype described above, in many cases, the placement, also and especiallyincluding the endoscopic placement, as well as the removal of thecontact element at or from the treatment site in the body cavity causesproblems.

In view of these problems in the state of the art, the invention isbased on the objective of providing a negative pressure treatmentarrangement, which can be arranged at a treatment site in a body cavitywithout any problem and be also removed again from this treatment site,as well as a film for producing a corresponding contact element.

According to the invention, this objective is achieved by an enhancementof the prior art negative pressure treatment arrangements, which isessentially characterized in that, at least in sections, the open-cellcontact element is embodied tubular, having an outer and/or an innerboundary surface that at least partially encircles a tube axis.

According to the invention, with respect to its shape and features, thecontact element, which may, for example, instead be embodied as afluid-collecting element for collecting fluids or gases, may be adaptedto the drainage tube required for the application of the negativepressure and for the outward-conducting of body fluids and gas. It maybe embodied in such a way that, with respect to the tube axis, it doesnot radially extend beyond the drainage tube. In this case, it can beintroduced into the body cavity without any problems and also be removedfrom it again.

In other embodiments of the invention, in the area of the contactelement or fluid-collecting element, the drainage tube may widen,continuous widening for the purpose of simple introduction of thecontact element into the body cavity or removal from it having proven tobe particularly advantageous. The contact element, embodied as afluid-collecting element, may be connected fluid-conductively to achannel-shaped lumen of a drainage tube in such a way that a tubulardrain is created, in which the open-cell fluid-collecting element aspart of the tube wall and the drainage tube forming afluid-communicating element are structurally interconnected.

Overall, the invention is based on the following knowledge:

Endoscopic placement as well as removal of an open-cell polyurethanesponge sewn to a drainage tube can be problematic due to the size of thepolyurethane sponge as well as its volume and its diameter.

As a result of the incongruity of the diameters of the fluid-collectingmeans or polyurethane sponge serving as contact element and thefluid-communicating element or drainage tube, placement and removal ofthe drain may be difficult.

The placement and particularly also any accidental uncontrolled removalof a conventional negative pressure treatment system being used in theupper gastrointestinal tract with outward-conduction from mouth or nosemay cause airway obstruction and, therefore, result in alife-threatening situation for the patient.

For placement and removal of a drain, it is advantageous if thefluid-collecting means, or contact element, and the fluid-communicatingelement, or drainage tube, have the same diameters and continuouslymerge into each other.

The drainage action effectiveness of a negative pressure drain does notdepend on the volume of the contact element or sponge element. Instead,using a sponge element many times smaller compared to the wound cavityor body cavity to be treated, wound healing that is equally good as witha contact element adapted to the size of the body cavity can be achievedbecause a small sponge element may suffice for draining a large woundand the wound with the sponge element collapses subject to the suctionabove the sponge element. Related thereto, it also became obvious thatthe wall of a drainage tube can be produced as an open-cell contactelement or fluid collecting element, the open-cell wall area of thedrainage tube or the wall area of the drainage tube formed by thecontact element needing to be only a few millimeters thick to allow itsuse as a vacuum sponge drain. The drainage tube or parts of the drainagetube can be provided with a curvature (pigtail).

In contrast to a sponge sewn to a drainage tube having become firmlyattached by suction to a wound during the negative pressure treatment,there is hardly any chance any more for a contact element embodiedaccording to the invention, when removed from the body cavity, to tearaway from the drainage tube. Within the scope of the invention, varioustypes of open-cell fluid-collecting elements can be combined with eachother, allowing the placement of the drains and the therapy usingspecially equipped drains and accessories to be simplified.

The invention results in numerous new therapy options and applications,which are particularly exploitable in wound treatment and in surgerycomplication management. Particularly, when using negative pressuretreatment arrangements according to the invention, in which contactelement and communication element are structurally combined in onedrainage tube, the life-threatening risk of airway obstruction, which isespecially liable to occur in a case of accidental removal ordislocation during application in the upper gastrointestinal tract, isprevented.

In a preferred embodiment of the invention, a tubular drain is used,which structurally combines in itself the fluid-collecting element(contact element) and the fluid-communicating element of the drain. As aparticular advantage, negative pressure treatment arrangements accordingto the invention can be used within the framework of endoscopic vacuumtherapy. Appropriate arrangements can also be used for intraabdominal,thoracic drainage after surgery, in wound treatment, relief of abscessesand during wound healing problems. In particular, a negative pressuretreatment arrangement according to the invention can be used inintestinal anastomoses prophylaxis and in the treatment of anastomoticinsufficiencies and intestinal perforations. The range of applicationsis very wide.

The fluid-communicating element, which, according to a preferredembodiment of the invention, is structurally combined with thefluid-collecting element, will hereinafter be referred to asfluid-communicating collection element and abbreviated “FE”. In an FEaccording to the invention, flexible negative pressure-stable drainagetubes may be involved, in which the wall or portions of the tube wallare designed as open-cell contact elements or fluid-collecting elements.Thus, by means of the open-cell contact elements as constituent parts ofthe drainage tubes fluids or gases can be drained.

The FE is fluid-conductive and equipped with open-cell fluid-collectingsegments or contact elements, which consist of the wall or parts of thewall of the FE. It is particularly advantageous to have the open-cellfluid-collecting segments of the FE located at the distal end of thetube. The open-cell fluid-collecting segment or contact element mayinstead be located in a section between the proximal or distal end ofthe tube. In this embodiment of the invention, the fluid-collectingsegment is expediently located in the central portion of the FE.

The FE may be provided with only one or else two, three or a pluralityof fluid-collecting segments or contact elements. Fluid-collectingsegments or contact element—elements may have a length of a few mm toseveral cm. When specially indicated, e.g. when complete evacuation ofthe stomach or other long intestinal stretches is necessary or forsecuring and covering a defect in the esophagus, fluid-collectingelement portions or open-cell contact elements having a length of morethan 20 cm, esp. 30 cm or more, are used. The drain is also especiallysuitable for the additional securing of a critical anastomosic situationat sutures in the entire gastrointestinal tract to prevent post-surgeryanastomotic insufficiency.

The fluid-collecting element or contact element may consist of anopen-cell elastic compressible polyurethane sponge element. Preferably,the contact element will have a cell size of 200 μm to 1000 μm, esp. 400μm to 600 μm. The fluid-collecting element or contact element mayinstead be formed of a one-, two- or multilayer open-cell film or beprovided with such a film. Corresponding films are described in EP 2 427477 A. By express reference thereto, the disclosure content of thisdocument is hereby incorporated in the specification herein with respectto the embodiment of open-cell multilayer films.

Within the scope of the invention, the use of a combination of anopen-cell polyurethane sponge element and an open-cell film forobtaining an open-cell fluid-collecting element or contact element isalso intended. The fluid collecting element may consist of an open-cellplastic material. Preferably, polyurethane, polyvinyl and polyethylenewill be used as materials for the FE. If the fluid-collecting segment orcontact element is externally covered by an open-cell film, it has thepurpose of improving the slidability of the FE. The design withopen-cell films as contact elements also allows a structure having aminimal diameter accompanied by good fluid conduction. Moreover, thefurnishing with films increases the tensile strength of the FE.

The contact element embodied as a fluid-collecting element isexpediently connected fluid-conductively to the fluid-communicatingelement or drainage tube. The fluid-communicating element preferablyconsists of a drainage tube having a central fluid-conductive channel,which is conducted onward as a tube into the fluid-collecting element orcontact element and is fluid-conductively connected here, by way oflateral ports, to the open-cell fluid-collecting element, which is partof the wall of the fluid-communicating element. The fluid-communicatingelement or drainage tube preferably consists of a tube having a centralchannel and additional channels, which are located in the wall of the FEand which are also fluid-conductively connected to the fluid-collectingsegment or contact element. The fluid communication element may consistof a tube having a plurality of channels or lumens.

The fluid-communicating element may have a drainage tube, which isembodied by a plurality of fluid-conductive channels. Thefluid-conductive channels may be equilumenous or have different lumens.The channels may be fluid-conductively interconnected. The channels ofthe fluid-communicating element may be used for suctioning and flushing.Into the channels, a guide wire, measuring probes or instruments can beintroduced. As far as their lengths and arrangements in the FE areconcerned, the channels may be dimensioned in such a way that individualchannels are connected to individual fluid-collecting elements orcontact elements. One or a plurality of channels in FE may also bedesigned in such a way that they extend several centimeters ordecimeters beyond the FE per se and/or can be used as feeding probe.This is a particular advantage in the intraluminal application of theprobe in the upper gastrointestinal tract.

In a preferred embodiment of the invention, a guide wire may beintroduced into the FE, by way of which the FE can slide. The FE canhave an overall length of 80 cm to 250 cm.

Because during a pull-through maneuver or a removal maneuver, thetensile strength exerted on the FE is not insubstantial, it ispreferably designed traction-resistant and break-resistant so that itcannot be torn off. Preferably, a tensile strength of 50 N, esp. 100 N,expediently of up to 200 N must exist. The FE should also be radiopaque.Within the scope of the invention, it has proven to be expedient if theFE cannot be kinked against itself because kinking disrupts the onwardconduction of negative pressure or the evacuation of secretions.

The FE that is conducted out of the body cavity may be connected, by wayof connecting elements, to a negative pressure generating system, esp.an electronic vacuum pump. If both the proximal and the distal leg ofthe fluid-communicating element are conducted outward, a negativepressure or suction may be applied at both the distal and/or theproximal end. Negative pressures in the range between 40 mm Hg and 200mm Hg will be used. In the thoracic application, lower negativepressures will also be used.

Preferably, an FE according to the invention will have an outer diameterof 2 mm to 20 mm. In a particularly preferred embodiment of theinvention, a drain equipped with an open-cell contact element accordingto the invention and having small-diameter can be endoscopically placedby way of the working channel of an endoscope. Expediently, all sectionsof the FE will have the same outer diameter. The open-cellfluid-conductive fluid-collecting segment(s) or contact element(s) ofthe drain preferably merge continuously into the fluid communicationsections. This makes it possible to transnasally introduce a negativepressure treatment arrangement according to the invention when used inthe upper gastrointestinal tract. With prior art arrangements, this isnot possible. Moreover, the negative pressure treatment arrangementaccording to the invention can be more easily removed by pulling if thediameter of the contact element is adjusted to the diameter of thedrainage tube without any mechanical obstruction due to the contactelement design. This allows the use of a negative pressure treatmentarrangement according to the invention as a cutaneouslyoutward-conducted target drain during surgery or for fluid drainage inall body cavities. Negative pressure treatment or vacuum therapy can beused in these locations and removal of the drain is possible without anynew surgical intervention.

By way of the FE, within the scope of the invention, a flushingtreatment can also be carried out. In particular, in case of placementof the FE in the central section and outward conducting of both fluidcommunication legs or drainage tubes, one of the legs can be used forsuction and the other for flushing.

Into the wall of the FE, in the longitudinal direction, wires or threadscan be incorporated, by means of which stability and/or tensile strengthof the FE can be increased and, as a result, tearing off of the FE canbe prevented.

The distal end of the FE is expediently conical in its design,terminating in a point. This facilitates the drain placement maneuver.As a particular advantage, the conical point of the drain will be softand atraumatic in its design, in order to avoid injury to adjacenttissue.

At the distal end of the fluid-communicating element or drainage tube,at the fluid-collecting element or contact element or in thefluid-collecting element, advantageously, a device will be attached,which can be grasped using pliers, hooks, sling or another placementinstrument. In particular, a thread or wire loop may be attached.Particularly preferred, a metal or plastic gripping bead may beprovided. In particular, a metal or plastic eyelet may be attached. Athread may also be attached. These devices are preferably designedtraction-resistant so that the drain or negative pressure treatmentarrangement on these elements can be drawn through tissue, intestinallumina and fistulas. The devices are designed to be flexible andatraumatic.

The placement of a negative pressure treatment arrangement according tothe invention can be implemented using a placement instrument in anorthograde manner subject to endoscopic vision. In the presence of anadditional outward connection, using the placement instrument or thefixed thread, placement can also be performed applying thepull-(through) technique. The change maneuvers can be greatly simplifiedby using the pull-through technique.

In the embodiments of the invention hitherto described, the open-cellcontact element of the negative pressure treatment arrangement accordingto the invention will be used in conjunction with a drainage tube fordraining fluids or gases from a body cavity. Additionally oralternatively, the negative pressure treatment arrangement may comprisea tubular hollow body for medical applications in the human or animalbody, its outside being provided with the contact element, wherein thecontact element consists of a gas and fluid-impermeable film ormembrane, its outward-facing side having an open-cell surface, alongwhich fluids and/or gases flow, and its inward-facing side preferablyhaving an open cell-free fluid and/or gas-tight surface.

Intestinal wall defects and airway leaks can entail the most seriousdisease patterns. Despite complex surgical procedures and intensivemedical treatment, they are encumbered by high mortality rates.

For bridging and sealing defects in the gastrointestinal tract, as analternative to surgical therapy, self-expanding metal and/or plasticstents are in use. For this purpose, the stents can be fully orpartially covered using a gas and/or fluid-impermeable film coating.They are then referred to as covered stents. The covering achieves afluid and gas-tight barrier between the inner lumen and the stentexterior. In principle, the structures involve self-deployable hollowbodies or tubes, which are placed by means of a set of placementinstruments.

Likewise, for sealing of defects, tubes are used that, in principle,consist of plastic pipes, both ends of which are open. Stents and tubesare also used for bridging lumen-obstructing obstacles, such ascancerous tumors. Sealing by a covered stent is caused when the stentdeploys and its outside is pressed against the intestinal wall. Adisadvantage of stents is the deficient sealing in case of a lumenincongruity. Such a condition always exists when, during intestinalsurgery, various lumens are linked by a suture. This occurs, forinstance, in the case of a sutured connection of esophagus and stomach.If, in this area of the suture, e.g. in the transition from esophagus(small lumen) and stomach (large lumen), a leak exists, sealing bydeployment of a stent is usually not complete. This situation frequentlyarises in anastomosis situations. This may complicate the treatment ofpostoperative leaks using stents and tubes. The stent deploys afterrelease and is supposed to press against the intestinal wall and becomeanchored in it and provide sealing against the mucous membrane in doingso, while a tubus can only achieve a bridge along the course of thelumen, without exerting any outward expansion pressure.

Another problem of stents and tubes is their dislocation. It occurs ifthe hollow bodies cannot become sufficiently anchored in the intestinalwall.

Another complication of stents and tubes is the perforation as a resultof the hollow body located in the intestinal lumen, through the wallfrom inside outward. Perforations occur particularly on the funnel-likeflare of the tubular hollow bodies.

A new possibility for treating leaks, e.g. on the esophagus, the stomachor caused by excessive distention, but also at the rectum, consists inthe method of endoscopic negative pressure treatment or vacuum therapy.For this purpose, open-cell polyurethane foam drains are inserted byintracavitary and intraluminal endoscopy and subjected to negativepressure by way of a drainage line. The suction effect causes theattachment of the sponge element by suction to the intestinal wall, withsealing of the covered defect and induction of a secondary wound, whichcan then heal by itself.

According to this aspect of the invention, it is proposed to combine thetechnical advantages of vacuum therapy with a stent or tubus using aunilaterally open-celled film or a unilaterally open-celled contactelement. In doing so, the disadvantages in the scope of the inventiondescribed above are eliminated or corresponding problems are solved.Patient safety is increased by avoiding stent-caused complications andthe indication range of the therapy is expanded. Numerous newtherapeutic options are opened, and esp. in the management of surgicaland endoscopic complications, tent and tubus can be used. Theapplication should be possible in the human and the animal body.

In accordance with this aspect of the invention, the jacketing of aself-expanding metal and plastic mesh stent is carried out using anopen-cell contact element in the form of a unilaterally open-celledfilm, the shape of the film being used as contact element correspondingto the shape of the stent or tubus being embodied at least partiallyencircling a tube axis. The special film forming the contact element mayconsist of a gas and fluid impermeable membrane. This membrane has twosides, which differ from each other in their characteristics.

One side of the membrane is open cell-free. This side will be situatedon the metal mesh wires or the plastic mesh of the stent and will bestructurally connected to it. The contact element embodied by the filmcan be permanently connected to the wires or the mesh by gluing and/orwelding. The film forms the inside of the tubular hollow body, both endsof which are open.

The other side of the membrane is embodied by the outside of thistubular hollow body. It has an open-cell surface. This surface ischaracterized in that, along this film side and/or this side of thecontact element, gases and fluids can freely communicate, move and flow.As a result of the open-cell surface structure, the film or the contactelement on this side has the characteristics of a fluid-collectingelement. This open-cell side of the surface can be subjected to negativepressure. When the negative pressure is applied to this side, as aresult of the open-cell structure, suction directed toward the negativepressure source becomes possible across the entire open-cell filmsurface. This open-cell film side or this open-cell contact element sidecomes into contact with the surrounding tissue and, as a result ofnegative pressure, adheres to the tissue.

In this way, the inadequate sealing of conventional covered stents, suchas in the case of incongruity of intestinal lumens, can be compensated.The outside of the stent adheres to the intestinal wall like a suctioncup by means of the (unilaterally) open-cell contact element subject tosuction. In this way, the stent is fixed to the placement site,preventing dislocation, which is a typical complication when usingconventional stents. Experience has shown that draining major amounts offluid by means of the negative pressure is not what matters but whatdoes matter is producing an intimate connection by means of the suctionbetween the intestinal wall and the stent.

Preferably, in the proximal and/or distal peripheral area of the contactelement or the film jacketing, the open-cell outside merges into anopen-cell-free surface structure, so that, as a result, in theperipheral area of the film, a boundary that is not fluid-conductive iscreated. This facilitates the development of negative pressure appliedto the open-cell surface. The open-cell structure of the film side orcontact element side can be achieved by a differing design of thesurface structure of the open-cell film side. The open-cell structurecan, for instance, be achieved by mesh, nub, finger or channel-shapedstructures. The cell size should be between 200 μm and 1000 μm. Thenegative pressure is preferably generated by means of an electricallycontrollable pump. The negative pressure can, however, instead begenerated by means of a vacuum bottle. According to knowledge obtainedfrom endoscopic vacuum foam therapy, the necessary negative pressure ispreferably between 40 mm Hg and 200 mm Hg.

The negative pressure can be transferred using a fluid-communicatingelement, which preferably consists of one or a plurality of negativepressure-stable tubes, which are fluid-conductively connected to theopen-cell side of the contact element. The fluid-communicating elementmay be branched fan-like or root-like on the open-cell film side. Thus,the suction action on the entire surface side can be optimized. Thefluid-communicating element may be designed removable, i.e. it may bedetachable from the tubular hollow body (tubus or stent), so that thestent can be used even without any negative pressure application. As aresult of the removability, it is possible to perform the vacuum ornegative pressure treatment during the first therapy days and then toterminate suction while still leaving the stent in the treatment site.Due to this property, it is possible to vary the configuration ofstents. A typical stent configuration is the tulip-shaped, funnel-likeoutward port of the lumen. This intends to achieve improved sealing andanchoring of the stent on the wall.

Complications frequently observed in the use of stents are perforationsby these tulip-shaped extensions. In a stent equipped according to theinvention, having a unilaterally open-celled surface, adhesion to thewall is assured by the negative pressure, so that the funnel shape canbe minimized. In a preferred embodiment of the invention, the funnelshape is completely omitted. This increases substantially the patientsafety when using stents in the gastrointestinal tract. Stent-relatedcomplications as a result of perforations and dislocations can beprevented. At the same time, the efficacy of the stent is optimized. Inthis aspect of the invention, the contact element is expedientlyembodied as a film. The film can be thin-walled and/or elastic and/orflexible and/or transparent.

Within the scope of the use of tubular hollow bodies having open-cellcontact elements according to the invention, the application of thevacuum or negative pressure therapy on the bronchial system in cases oftracheal or bronchial injuries becomes particularly possible, withoutbeing limited thereto. This creates completely new therapy options forthese hard-to-treat disease patterns. The application of endoscopicvacuum therapy is hitherto not possible for this indication. It isconceivable that it will become possible to avoid numerous surgeries bythe use of this novel treatment option.

The preceding statements apply equally to a tubus, which consists of abilaterally open plastic tube, the outer surface of which is enclosed ina tubular jacket by means of a unilaterally open-celled film or aunilaterally open-celled contact element.

A special form of a unilaterally open-celled tubus is a tubus, in whichthe tubus wall of the tubus per se is designed with the characteristicsof the unilaterally open-celled film or the unilaterally open-celledcontact element. This means that the tubus consists of a hollow tube, inwhich the wall is unilaterally open. The wall is not permeable to gasand fluid. The lumen situated inside is open cell-free. The outersurface side of the tube surface structure is designed as an open-cellstructure and embodied as an open-cell contact element.

A special embodiment of a unilaterally open-celled tubus is anovertube-tubus for endoscopes. The overtube can advantageously beprovided with a complete longitudinal slit.

A particular embodiment of a unilaterally open-celled tubus is a singleor dual lumen endotracheal intubation tubus. As an alternative or inaddition to tracheal sealing, subject to negative pressure suction, thetubus can endotracheally become attached by suction to the tracheal wallby way of one or a plurality of open-cell circular tubus segment(s).

A film according to the invention used to produce an open-cell contactelement of a negative pressure treatment arrangement according to theinvention is essentially characterized in that it consists of a gas andfluid-impermeable membrane, one side of which has an open cell-freesurface and the other side of which has an open-cell surface, alongwhich fluids and/or gases can flow. The open cell-free surface of a filmaccording to the invention may be at least partially designed to besmooth. Additionally or alternatively, it may also have textured surfaceareas. In particular, this surface may be provided with a groove-likeprofile or a mesh profile.

The other side of the film has an open-cell structure. The open-cellstructure of this surface is characterized in that fluids or gases canfreely move along this surface in all directions and communicate witheach other. When the open-cell surface side is placed on a body tissue,fluids and gases can move through the open-cell structure between thetissue surface and the film surface side. Negative pressure can beapplied in the interstice between the tissue and/or to the open-cellsurface side. A directed negative pressure can be applied in the space.This means that the fluids or gases can be aspired by one or a pluralityof negative pressure sources and move in the direction of these sources.Along this space of the open-cell surface side of the film, fluids andgases can flow directed by a negative pressure. Fluids and gases canlikewise be introduced into this space in the opposite direction fromthe outside. For example, a liquid medication can be supplied. Theopen-cell surface side can act as a medication carrier and be loadedwith special substances, such as antiseptics. By means of an appliednegative pressure, this film side can adhere by suction over a wide areaof the entire surface of body tissue or other closed surfaces. Theopen-cell structure remains intact upon application of the negativepressure.

The open-cell structure of the surface is a structural part of the filmper se. The film combines in itself the open-cell structure and the opencell-free structure or impermeability on the other side.

The open-cell structure is achieved by an open-cell surface structure ofthe film per se. The open-cell surface structure can be particularlyachieved using an open-cell mesh-type surface structure. It can beachieved by a nub-like and/or villus-shaped structure or a combinationof different surface patterns.

The open-cell structure of the surface can be achieved by applying anopen-cell material to the membrane, for instance. The surface can, inparticular, be loaded with a thin layer of an open-cell fluid-collectingelement. The fluid-collecting element can, in particular, be loaded witha layer of open-cell polyurethane foam.

The open-cell structure of one of the film sides can also be achieved inthat the film on the open-cell side consists of open-cell dual ormultilayer perforated films, for example according to EP-A-2424477. Withrespect to each other, these multilayer films are spaced in such a wayusing spacers that the membranes do not have any direct areal contactwith each other. The film membranes of the multilayer open-cell filmsare provided with a plurality of small perforations. These perforationsmay be arranged in an ordered pattern or they may instead be irregularlydistributed.

In the case of a multilayer film layer, the films in the peripheral areaof the film can advantageously be welded to each other without beingfluid-conductive, so that fluid conduction beyond the edge is notpossible. In the case of a single-layer unilaterally open-celled film,advantageously both film sides bilaterally merge into an open cell-freesurface structure of the film side. As a result, the unilaterallyopen-celled film is not fluid conductive in the peripheral area.

Depending on the application, the peripheral area may be provided withan adhesive on both the smooth open cell-free side and the open-cellside. In this way, the film can be glued to a wound like a band-aid,sealing and closing it.

As a result of the fluid-conductive connection to a fluid-communicatingelement, which is fluid-conductively connected to the open-cell filmside, using a negative pressure-generating system, e.g. an electronicpump or a vacuum bottle, negative pressure can be generated on theopen-cell film side. The fluid-communicating element may consist oftubular drainage lines. The tubular fluid-communicating elements may beintegrated in the film and be fluid-conductively connected to theopen-cell film side. The fluid-communicating elements may be branchedcapillary-like on the open-cell surface. Moreover, the closed film sidecan also be opened to be fluid-conductive and, by way of this port, thefluid-communicating element can be fluid-conductively connected to theopen-cell film side. This can be achieved by a fluid-conductive pelotte,which is glued to the film.

In a preferred embodiment of the invention, the peripheral area may alsohave a fluid-conductive open-cell structure. This may, for example, beadvantageous when applied in the open abdomen when the film is used toenclose an organ (e.g. the spleen or liver) and to subject its open-cellside to negative pressure. In this case, the peripheral area of the filmwill be closed, too, by the aspiration of tissue. Because in thisapplication no closed peripheral area is necessary, the film can befreely cut to size and adapted to the requirements. Because the film isunilaterally open-celled, the suction action is deployed only on thisside, while the organs abutting the closed side are not subjected to thesuction. This avoids damaging the organs that do not require anytreatment by the negative pressure. This is a particular advantage.

The film is, in particular, foldable and/or soft and atraumatic and/orelastic and/or transparent and/or not transparent and/or colored. Thefilm can be sewn, welded and glued.

The film thickness is preferably from 0.5 mm to 5 mm. If the film isused to equip a medical device, e.g. a self-expanding stent, an evenlower film thickness can be selected so that the stent can be compressedto the smallest possible size.

The film can be fluid-conductively connected together with otherfluid-collecting elements. It can, for example, be used as film in anocclusive dressing or in low-pressure wound therapy on external wounds.

The film may be folded or rolled into a multilayer film. In conjunctionwith a fluid-communicating element, it can be used as an active negativepressure film and/or an active film.

The film may be adapted to different body shapes. A glove or a face maskcan, for instance, be made from the film, so that a wound dressingadapted to the shape of the body can be put on like a garment.

In the peripheral area, the film is advantageously provided with anadhesive means, so that the dressing can be adhered to the skin.

By way of a fluid-communicating element, which is fluid-conductivelyconnected to the open-cell side of the film, negative pressure can beapplied to the wound or skin.

The negative pressure generates both a suction effect and a pressureeffect on the abutting tissue. As a result of the negative pressure, thewound secretion that is typically present at a wound is drained so thatthe wound is drained subject to slight compression.

It is particularly preferred to have the film designed transparent sothat the evaluation of a surface wound can be carried out through thedressing. If the film is loosely placed on a skin surface or a wound andis elastic, the applied negative pressure draws it all the way to thetissue surface and adjusts to it.

Another typical application example is the wound care after skintransplantation.

Using a film according to the invention, in particular including medicalinstruments or therapeutic devices can be technically equipped.Advantageously, it can be used in the areas where, on the one hand, afluid- and/or gas-tight boundary to an appliance or tissue is desiredand, on the other hand, drainage of fluids or gases along the film isadvantageous. Depending on the requirements, in this case, one as wellas the other film side may be advantageous in use. In this respect, itis particularly advantageous that the thin-walled film does not causeany substantial increase in the film-loaded unit.

As explained in detail above, so-called covered self-expanding stentsthat are used for treating leaks in the gastrointestinal tract, can beequipped with open-cell film. If the film is used here as cover film onthe stent (open-cell side toward the tissue, smooth closed side towardthe stent), conventional stent bridging by applying vacuum suction tothe abutting tissue is simultaneously possible.

Particularly advantageous would be such use in the case of a lumenincongruity of the intestinal lumens to be bridged or in the bronchialsystem. In the same way, tubes, overtube, probes, endoscopes, which areintroduced intracorporeally, can be enclosed in an open-cell wrap. Ifthe closed side is situated on the device side, the simultaneousapplication of the vacuum to the tissue and use of the vacuum therapy ispossible. If the open-cell side of the film is placed on the medicaldevice, this arrangement can serve as a protective enclosure for themedical device. As a result of the suction, the film terminates at thedevice and does not substantially contribute to any increase incircumference.

Advantageously, the outfitting of ventilation tubes and anesthesia tubesis also possible. Here, hitherto, sealing of the tubus vis-a-vis thetrachea using a balloon has been taking place. If, in this case, thetubus is equipped with a unilaterally open-celled film, sealing can beachieved by way of the vacuum. In the case of all medical instruments,in which fixation is performed by balloon expansion, fixing and sealingmay also take place by vacuum suction. Another example of outfittingdevices is the use of the film in vacuum endoscopy as an endoscopicexamination method for the small intestine. In analogy to single or dualballoon endoscopy, fixing of the overtube and the endoscope can takeplace by suction.

Hereinafter, the invention will be explained with reference to thedrawing, to which express reference is made with respect to all detailsthat are essential to the invention and not highlighted in detail in thespecification.

FIG. 1a is a representation of a negative pressure treatment arrangementaccording to the invention in the form of an open-cell drainage tube.Open-cell fluid connection segment 1 or contact element 1 is located atthe distal end of tubular fluid-communicating element 2. A guide wire 3is inserted into a channel 4.

FIG. 1b is a cross-sectional view of FIG. 1a . Fluid-collecting segment1 and fluid-communicating element 2 continuously merge into one another.Into both, by way of a channel 4, guide wire 3 is inserted. Channel 4 isfluid-conductively connected to fluid-collecting segment 1 or contactelement 1.

FIG. 1c is a representation of an open-cell drainage tube having aplurality of open-cell fluid-collecting segments 1 or contact elements1.

FIG. 2a is a representation of an arrangement according to the inventionin the form of an open-cell drainage tube. The open-cellfluid-collecting segment 1 or contact element 1 is located at the distalend of tubular fluid-communicating element 2. In fluid-communicatingelement 2, a three-lumen channel 4 a is arranged.

FIG. 2b is a cross-sectional view of FIG. 2a at the level offluid-communicating element 2. Centrally, a three-lumen channel 4 aexists.

FIG. 2c is a longitudinal sectional view of an open-cell drainage tubehaving two fluid-collecting segments 1. Each fluid-collecting segment 1or contact element 1 is fluid-conductively connected to a channel 4 b,which through fluid-communicating element 2.

FIG. 3a is a representation of an open-cell drainage tube. Open-cellfluid-collecting segment 1 or contact element 1 is located at the distalend of tubular fluid-communicating element 2. In fluid-communicatingelement 2, a plurality of small-volume channels 5 is located, whichextend fluid-conductively as far as fluid-collecting segment 1.

FIG. 3b is a cross-sectional view of FIG. 3a at the level offluid-communicating element 2, which is provided with a plurality ofchannels 5.

FIG. 4 is a longitudinal sectional view of an arrangement according tothe invention in the form of an open-cell drainage tube. Open-cellfluid-collecting segment 1 or contact element 1 is located at the distalend of tubular fluid-communicating element 2. In the wall of the tube,for increasing the tensile strength of the wall, a wire-shaped thread 6is located. It may also meander and run in winding curves 6 a.

FIG. 5 is a representation of an arrangement according to the inventionin the form of an open-cell drainage tube.

Open-cell fluid-collecting segment 1 or contact element 1 is located inthe center of a tubular fluid-communicating element 2.

FIG. 6 is a representation of an arrangement according to the inventionin the form of open-cell drainage tube. A spirally curved open-cellfluid-collecting segment 1 a is located at the distal end of tubularfluid-communicating element 2. A guide wire 3 is inserted into afluid-conductive channel 4.

FIG. 7 is a longitudinal sectional view of an arrangement according tothe invention in the form of an open-cell drainage tube. Open-cellfluid-collecting segment 1 or contact element 1 is located at the distalend of tubular fluid-communicating element 2. A tube 7 having aperforation 7 a at its end passes through. It can be used as a feedingtube. A channel 4 is fluid-conductively connected to fluid-collectingsegment 1.

FIG. 7a is an additional representation of FIG. 7. Open-cellfluid-collecting segment 1 or contact element 1 is located at the distalend of tubular fluid-communicating element 2. A tube 7 having aperforation 7 a at its end passes through. It can be used as a feedingtube. A channel 4 is fluid-conductively connected to fluid-collectingsegment 1.

FIG. 8 is a representation of the open-cell drainage tube. Variousvariants of the points of transition from fluid-collecting segment 1 tofluid communicating element 2 are represented.

FIG. 8a is a longitudinal sectional view of the transition fromfluid-collecting segment 1 to fluid-communicating element 2. Open-cellfluid-collecting segment 1 or contact element 1 is continuouslyconnected to fluid-communicating element 2. In fluid-communicatingelement 2, a fluid-conductive channel 4 is provided.

FIG. 8b is a longitudinal sectional view of the transition fromfluid-collecting segment 1 to fluid-communicating element 2. Open-cellfluid-collecting segment 1 or contact element 1 is continuouslyconnected to fluid-communicating element 2. In fluid-communicatingelement 2, a fluid-conductive channel 4 is located, which is conductedon as a negative pressure-stable tube in fluid-collecting segment 1 andis fluid-conductively connected to fluid-collecting segment 1 by lateralperforations 8. A guide wire 3 is inserted into channel 4.

FIG. 8c is a longitudinal sectional view of the transition fromfluid-collecting segment 1 to fluid-communicating element 2. Open-cellfluid-collecting segment 1 or contact element 1 is continuouslyconnected to fluid-communicating element 2. In fluid-communicatingelement 2, a fluid-conductive channel 4 is located, which is conductedon as a negative pressure-stable tube in fluid-collecting segment 1 andis fluid-conductively connected to fluid-collecting segment 1 by lateralperforations 8. Fluid-collecting segment 1 is covered by a film 9 havingfluid-conductive perforations 9 a. Film 9 merges continuously intofluid-communicating element 2. The exterior covering of film 9 isintended to bring about improved slidability of the drain to improveplacement and removal.

FIG. 8d corresponds to the longitudinal sectional view in FIG. 8c . Inaddition, open-cell fluid-collecting segment 1 or contact element 1 isprovided and/or permeated by an additional film 9 c havingfluid-conductive perforations 9 a.

FIG. 8e corresponds to the longitudinal sectional view in FIG. 8d . Inaddition, open-cell fluid-collecting segment 1 or contact element 1 isprovided and/or permeated by an additional film 9 d havingfluid-conductive perforations 9 a. The multilayer film design increasesthe tensile strength. The design of open-cell multilayer films 9, 9 c, 9d is intended to achieve maximum fluid conduction in conjunction with asmall drain diameter.

FIG. 8f corresponds to the cross sectional view of a drain having fourtubular film layers 9, 9 c, 9 d, 9 f and being provided with centralfluid-conductive channel 4 a.

FIG. 9 is a plan view of a self-expanding metal or plastic mesh stent,which consists of a self-expanding metal or plastic wire mesh 14. Thestent is completely jacketed by a unilaterally open-celled film 9 or acontact element 1, the outside 12 of which has an open-cell structureand the inside 11 of which that is open cell-free abuts metal or plasticmesh wires 14. The outer open-cell surface is fluid-conductivelyconnected to drainage tube 13. Both ends are flared funnel-like.

FIG. 10 is a longitudinal sectional view of FIG. 1. Surface side 11 ofthe film, situated inside, is open cell-free and abuts the metal orplastic mesh wires 14. Open-cell surface side 12 of the film is situatedoutside and is fluid-conductively connected to a tubular drain 13. Bothends are flared funnel-like.

FIG. 11 is a plan view of a self-expanding v-shaped metal or plasticmesh stent, which consists of a self-expanding metal or plastic wiremesh 14. The stent is completely jacketed in unilaterally open-celledfilm, the outside 12 of which has an open-cell structure and the inside11 of which that is open cell-free abuts the metal or plastic mesh wires14. The outer open-cell surface 12 is fluid-conductively connected to adrainage tube 13. This embodiment of a y-shaped stent intends illustratethe possibility of its application in the tracheobronchial system in anexemplary manner.

FIG. 12 is a plan view of a tubular tubus, the wall of which in thecenter portion of the tubus has a circular unilaterally open-celledstructure. The externally visible open-cell structure of the wall ismarked 12. It is fluid-conductively connected to a tubular drainage line13, which is brought up from the inside of the tubus. One end is flaredfunnel-like.

FIG. 13 is a longitudinal sectional view of FIG. 4. The wall of thetubus is designed unilaterally open. The inside 11 of the wall is opencell-free, the outer wall 12 has open cells in the center part of thetubus. From inside, by way of a perforation 13 a, a drainage line 13,fluid-conductive, is brought up to the outside. One end is flaredfunnel-like.

FIG. 14 is a plan view of a special form of a tubus. It involves anintubation tubus. In its distal portion, tubus tube 15 is enclosed by anopen-cell film. A fluid-conductive tube 13 leads to open-cell surface12.

FIG. 15 is a longitudinal sectional view of FIG. 6. The distal portionof tubus tube 15 is enclosed by an open-cell film. 12 is the open-cellsurface situated outside. Open cell-free surface 11 abuts tubus tube 15.A fluid-conductive connection to a tube 13 exist.

FIG. 16 is a longitudinal sectional view of a tubus, in which the wallof the tubus per see is open-celled 12 on the outside and open cell-free11 toward the inside. Situated in the wall are the tubular drainagelines 13, which are fluid-conductively connected to the open-cellsurface.

FIG. 17 is a cross-sectional view of a unilaterally open-celled filmhaving an open cell-free surface side 21 and an open-cell surface side22.

FIG. 18 is a plan view of a unilaterally open-celled film having an opencell-free surface side 21 and an open-cell surface side 22. The film iscut to size to be rectangular.

FIG. 19 is a cross-sectional view of a unilaterally open-celled filmhaving an open cell-free surface side 21 and an open-cell surface side22. In the peripheral area of the film, both the open-cell surface side21 a and the open-cell surface side 22 a are open cell-free. Peripheralarea 21 a and/or 22 a can be provided with an adhesive so that the filmin peripheral area 21 a, 22 a is closed off gas and air-tight when theyare glued down and/or glued to each other.

FIG. 20 is a cross-sectional view of a unilaterally open-celled filmhaving an open cell-free surface side 21 and an open-cell surface side22. To open-cell surface side 22, fluid-conductively, a tubularfluid-communicating means 23 is connected, which is brought up toopen-cell surface side 22 from the outside and fluid-conductivelyconnected to it.

FIG. 21 is a plan view of a unilaterally open-celled film having an opencell-free surface side 21 and an open-cell surface side 22. To open-cellside 22, fluid-conductively, two tubular fluid-communicating means 23are connected, which are brought up to open-cell surface side 22 fromthe outside and fluid-conductively connected to it.

FIG. 22 is a cross-sectional view of a unilaterally open-celled filmhaving an open cell-free surface side 21 and an open-cell surface side22. By means of a pelotte 24, the tubular fluid-communicating means 23is fluid-conductively connected, by way of a port 21 b of the opencell-free surface side 21, to open-cell surface side 22. 25 marks thetransition, where, in the peripheral area, both surface sides merge intoan open cell-free surface (21 a and 22 a).

FIG. 23 is a plan view of FIG. 22. The fluid-conductive pelotte 24 iscentrally attached to a rectangular film. In peripheral area 22 a, thefilm is bilaterally open cell-free. The transition to the open-cellsurface (not visible here) is marked 25.

FIG. 24 is an exemplary representation of a film adapted to a type ofclothing, in this case in glove form. On the outside is the opencell-free film side 21, tubular fluid-communicating means 23 areconducted to the open-cell film side (invisible, situated inside), oneof them by way of a pelotte 24. The termination 26 of the glove isglue-bonded to the skin, the inner invisible transition to the open-cellside of the peripheral area is marked 25.

REFERENCE LIST

-   1, 1 a Fluid-Collecting Segment/Contact Element-   2 Fluid-Communicating Element-   3 Guide Wire-   4, 4 a, 4 b, 5 Channel-   6 Wirelike Thread-   6 a Winding Curve-   7 Tube-   7 a, 8, 9 a, 13 a Perforations-   9, 9 c, 9 d, 9 f Film-   11 Inside/Surface Sides of the Film Situated Inside-   12 Outside/Surface Sides of the Film Situated Outside/Exterior Wall-   13 Drainage Tube/Drainage Line-   14 Metal or Plastic Mesh Wires/Metal or Plastic Wire Mesh-   15 Tubus Tube-   21 Surface Side of the Film (Open Cell-Free)-   22 Surface Side of the Film (Open-Cell)-   21 a, 22 a Peripheral Area-   21 b Port-   23 Fluid-Communicating Means-   24 Pelotte-   25 Transition-   26 Termination (Glove)

The invention claimed is:
 1. A negative pressure treatment arrangementcomprising: a flexible, negative pressure-stable, drainage tube formingat least one channel-shaped lumen; at least one open-cellfluid-collecting element through which a negative pressure is capable ofbeing generated in a body cavity and fluids and gases are capable ofbeing collected, the fluid-collecting element having, at least in part,an outer boundary area and an inner boundary area that encircle atubular axis and; wherein the fluid-collecting element is connected tothe drainage tube such that the fluid-collecting element is in fluidcommunication with the channel-shaped lumen of the drainage tube; andwherein the fluid-collecting element and the drainage tube arestructurally interconnected such that the outer boundary of thefluid-collecting element and the drainage tube have the same diameterand continuously merge into each other such that no part of the drainagetube extends into the fluid-collecting element.
 2. The negative pressuretreatment arrangement according to claim 1 wherein the fluid-collectingelement forms at least one channel-shaped lumen in fluid-communicationwith the channel-shaped lumen of the drainage tube.
 3. The negativepressure treatment arrangement according to claim 2 further comprising aguide wire extending into the channel-shaped lumen of thefluid-collecting element and the channel-shaped lumen of the drainagetube.
 4. The negative pressure treatment arrangement according to claim1 wherein the fluid-collecting element is located at the distal end ofthe drainage tube.
 5. The negative pressure treatment arrangementaccording to claim 4 wherein the fluid-collecting element is spirallycurved.
 6. The negative pressure treatment arrangement according toclaim 1 wherein the fluid-collecting element is located between theproximal end and the distal end of the drainage tube.
 7. The negativepressure treatment arrangement according to claim 1 further comprising aplurality of fluid-collecting elements spaced apart on the drainagetube.
 8. The negative pressure treatment arrangement according to claim1 wherein the fluid-collecting element comprises an open-cell sponge. 9.The negative pressure treatment arrangement according to claim 1 furthercomprising a film having fluid-conductive perforations, the filmcovering the fluid-collecting element and merging continuously into thedrainage tube.
 10. The negative pressure treatment arrangement accordingto claim 1 further comprising an open-cell film covering thefluid-collecting element and merging continuously into the drainagetube.
 11. The negative pressure treatment arrangement according to claim1 wherein the fluid-collecting element comprises a plurality ofopen-cell film layers.
 12. The negative pressure treatment arrangementaccording to claim 1 wherein the drainage tube forms a plurality ofchannel-shaped lumens.
 13. The negative pressure treatment arrangementaccording to claim 1 further comprising a wire thread extending into thewall of the drainage tube and the wall of the fluid-collecting element,wherein the wire thread increases the tensile strength of thefluid-collecting element and the drainage tube such that the tensilestrength of the fluid-collecting element and the drainage tube is 50 Nto 200 N.
 14. The negative pressure treatment arrangement according toclaim 1 further comprising a vacuum pump connected to the drainage tube,wherein the vacuum pump is capable of applying a negative pressure tothe arrangement of between 40 mm Hg and 200 mm Hg.
 15. A method oftreating a wound using vacuum therapy, the method comprising: placing anegative pressure treatment arrangement according to claim 1 near awound; connecting the negative pressure treatment arrangement to avacuum pump; applying a negative pressure to the negative pressuretreatment arrangement, wherein fluids and gases are conducted away froma wound through the fluid-collecting element and the drainage tube topromote wound healing; and removing the negative pressure treatmentarrangement by pulling without mechanical obstruction due to thediameter of the outer boundary of the fluid-collecting element and thediameter of the drainage tube being the same.